Factors Influencing Participation in PRADO and Telemedicine Interventions in Heart Failure (PARTI-PARC)

April 10, 2026 updated by: University Hospital, Montpellier

Research Into Factors Determining Participation in Two Interventions Modifying the Care Pathways of Patients With Heart Failure in Eastern Occitanie: PRADO-IC and Telemedicine

Patients with heart failure (HF), after hospitalization, present a marked fragility. Interventions improving the coordination of care actors at the time of discharge from hospitalization have been tested and have shown, in preliminary studies, a reduction in rehospitalizations for heart failure and all-cause mortality.

Among these promising devices, two have recently been deployed nationwide.

  • The return home program for IC patients (PRADO IC), set up by the Health Insurance, aims to facilitate the return and stay at home after hospitalization. It offers assistance with the initiation of outpatient medical follow-up, nursing follow-up for 2 to 6 months depending on the severity of the patient, and a follow-up log facilitating the exchange of information.
  • At the same time, as part of the ETAPES (Telemedicine experiments for the improvement of healthcare pathways) program of the Health Insurance, the deployment of telemedicine for remote monitoring of heart failure pursues a comparable objective of reducing rehospitalizations.

These two systems are widely deployed on a national scale, and are intended to be universal.

Our hypothesis is that adherence to care transition and telemedicine programs, and therefore their effectiveness, may depend on their association, as well as socio-demographic, cultural, and geographical factors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with heart failure (HF), after hospitalization, present a marked fragility: in France, in the first year, 29% die and 45% are rehospitalized for HF. Interventions improving the coordination of care actors at the time of discharge from hospitalization have been tested and have shown in preliminary studies a reduction in rehospitalizations for HF (relative risk (RR) from 0.51 to 0.74) and all-cause mortality (RR 0.75 to 0.87).

Among these promising devices, two have recently been deployed nationwide.

  • The return home program for IC patients (PRADO IC), set up by the Health Insurance, aims to facilitate the return and stay at home after hospitalization. It offers assistance with the initiation of outpatient medical follow-up, nursing follow-up for 2 to 6 months depending on the severity of the patient, and a follow-up log facilitating the exchange of information. It is based on the assumption that these actions will improve the coordination of care between the hospital and the city, and between home nurses and doctors. In addition, nurses reinforce therapeutic patient education (TPE), whether or not it is initiated in a setting dedicated to TPE.
  • At the same time, as part of the ETAPES program of the Health Insurance, the deployment of telemedicine for remote monitoring of heart failure pursues a comparable objective of reducing rehospitalizations. It is based on the hypothesis that the early signs of cardiac decompensation can be diagnosed by telemonitoring and trigger earlier and therefore less aggressive management for similar effectiveness.

These two systems are widely deployed on a national scale, and are intended to be universal.

However, three points can call into question the effectiveness of this deployment: their evaluation is often difficult, the extrapolability of randomized studies to health systems and different populations is low, and the complementarity of two independently constructed programs has never been been studied so far.

  1. The preliminary data concerning the PRADO were epidemiological, historical, comparative before-elsewhere, on the SNIIRAM (National health insurance inter-scheme information system) databases, without optimal consideration of clinical and cultural confounding factors.
  2. The acceptability of these programs by all health professionals (and therefore how they choose to deploy such and such a system for a given patient) and patients in the French context is not known.
  3. The PRADO system and telemedicine solutions, acting differently, could be synergistic and therefore multiply the benefits obtained. However, in practice, some patients experience these programs as intrusive, and it is possible that their adherence is in fact all the worse when two programs are implemented. Similarly, from the prescriber's point of view, the way in which the various possible combinations are chosen is unknown.

The answer to these three questions is necessary to guide the most effective deployment of these programs nationwide.

Our hypothesis is that adherence to care transition and telemedicine programs, and therefore their effectiveness, may depend on their association, as well as socio-demographic, cultural, and geographical factors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The target population consists of adult patients, suffering from heart failure, hospitalized for cardiac decompensation.

The source population consists of patients hospitalized for heart failure in cardiology departments of UH of Montpellier, Nîmes, Bassin de Thau and Béziers.

Description

Inclusion Criteria:

  • Adult patient
  • Patient hospitalized at the time of inclusion for cardiac decompensation, or cause of admission for which heart failure plays a decisive or aggravating role (co-infection, etc.) recognized by the clinician.
  • Patient agreeing to take part in this research (absence of non-objection)

Exclusion Criteria:

  • Refusal to participate
  • Pregnant or breastfeeding women, patients unable to give protected adult consent, vulnerable people (art.L.1121-6, L.1121-7, L.1211-8, L.1211-9)
  • Subject deprived of liberty by judicial or administrative decision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Group with PRADO

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M (6 months) visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

  • Girerd's questionnaire : The objective is to measure the medication compliance of patients during treatment
  • SSQ6 (Social Support Questionnaire 6) : which measures two dimensions of social support (satisfaction and availability). SSQ6 is an abbreviated form of SSQ (Social Support Questionnaire). A high SSQ score indicates more optimism about life than a low score.
Other: PRADO-IC

The CAM (Health Insurance Advisor) are part of the staff of the Primary Health Insurance Funds (CPAM). They are physically present in the establishments participating in the PRADO.

They are facilitators between city health professionals and the patient for their return home.

They assist the patient in making appointments with their general practitioner, their cardiologist, and the IDE (general care nurses) trained at PRADO-IC who will make the home visits.

After returning home, the CAM verifies, by two telephone calls at 1 week and 2 months, that the patient has initiated his outpatient follow-up.

IDE, trained in the therapeutic education of the IC patient according to the PRADO-IC device, carry out:

  • for NYHA (New York Heart Association) 1-2 patients: 8 home visits in two months.
  • for NYHA 3-4 patients: 8 home visits in 2 months, upon confirmation and prescription from the physician, 8 visits in the following 4 months.

The doctor carries out a long consultation at 2 months.
Group with PRADO + remote monitoring

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

  • Girerd's questionnaire
  • SUTAQ (Service User Technology Acceptability Questionnaire) : only for patients with remote monitoring.

the questionnaire has 22 items, measured on a Likert scale from 1 to 6, reflecting respectively more or less agreement with the statements of the items. The questionnaire has 5 subscales, each containing between 3 and 9 items.

  • SSQ6
Other: PRADO-IC

The CAM (Health Insurance Advisor) are part of the staff of the Primary Health Insurance Funds (CPAM). They are physically present in the establishments participating in the PRADO.

They are facilitators between city health professionals and the patient for their return home.

They assist the patient in making appointments with their general practitioner, their cardiologist, and the IDE (general care nurses) trained at PRADO-IC who will make the home visits.

After returning home, the CAM verifies, by two telephone calls at 1 week and 2 months, that the patient has initiated his outpatient follow-up.

IDE, trained in the therapeutic education of the IC patient according to the PRADO-IC device, carry out:

  • for NYHA (New York Heart Association) 1-2 patients: 8 home visits in two months.
  • for NYHA 3-4 patients: 8 home visits in 2 months, upon confirmation and prescription from the physician, 8 visits in the following 4 months.

The doctor carries out a long consultation at 2 months.

Device: Remote monitoring

Chronic Care Connect is intended for remote medical monitoring of patients suffering from chronic heart failure.

It consists of a web application (named NOMHADChronic™) and non-medical remote human assistance performed by qualified personnel.

Non-medical human assistance allows the following steps to be carried out:

  • characterization of alerts
  • structured follow-up of remote patients.

This non-medical human assistance is provided by:

  • nurses trained in therapeutic education and cardiology, Customer Relations Advisors, and logisticians.

Weight and symptoms (listed in an 8-question questionnaire) are collected respectively using a connected scale and the mobile application.

It allows, via a web browser:

  • to the personnel constituting the non-medical human assistance, to have access to the health data of the patients
  • remote monitoring doctors, to have access to the health data of each of their own patients, and to carry out medical remote monitoring procedures.
Group with remote monitoring

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

  • Girerd's questionnaire on therapeutic compliance
  • SUTAQ inspired digital tools acceptability questionnaire: only for patients with remote monitoring
  • SSQ6 social support questionnaire
Device: Remote monitoring

Chronic Care Connect is intended for remote medical monitoring of patients suffering from chronic heart failure.

It consists of a web application (named NOMHADChronic™) and non-medical remote human assistance performed by qualified personnel.

Non-medical human assistance allows the following steps to be carried out:

  • characterization of alerts
  • structured follow-up of remote patients.

This non-medical human assistance is provided by:

  • nurses trained in therapeutic education and cardiology, Customer Relations Advisors, and logisticians.

Weight and symptoms (listed in an 8-question questionnaire) are collected respectively using a connected scale and the mobile application.

It allows, via a web browser:

  • to the personnel constituting the non-medical human assistance, to have access to the health data of the patients
  • remote monitoring doctors, to have access to the health data of each of their own patients, and to carry out medical remote monitoring procedures.
Group without intervention

All patients seen in hospital and for whom the doctor will choose whether or not to offer one of the 2 solutions, alone or in combination, will be considered as included in the study, and their non-objection will be collected.

Subsequently, patients will benefit from follow-up for 6 months: V0 inclusion visit- V1 telephone contact at 1 month optional only for patients participating in one of the 2 programs and V2 consultation at 6 months. The 0 and 6M visits are part of the usual follow-up of patients hospitalized for heart failure.

Administration of questionnaires:

  • Girerd's questionnaire on therapeutic compliance
  • SSQ6 social support questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients participating in heart failure programs at 1 month
Time Frame: At 1 month

Participation corresponds to:

  • for the PRADO group: visits to the attending physician and home nurses, and appointments made with the cardiologist
  • for the remote monitoring group: completion of at least 80% of the weighings
At 1 month
Percentage of patients participating in heart failure programs at 6 months
Time Frame: At 6 months

Participation corresponds to:

  • for the PRADO group: visits to the attending physician and home nurses, and appointments made with the cardiologist
  • for the remote monitoring group: completion of at least 80% of the weighings
  • for the group without intervention: completion of the visit at 6 months
At 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of non-participation of patients
Time Frame: At inclusion
Describe the causes of non-participation, primary (when the intervention was proposed)
At inclusion
Number of non-participation of patients
Time Frame: through study completion, an average of 6 months
Describe the causes of non-participation secondary (after initial acceptance)
through study completion, an average of 6 months
Percentage effectiveness of pathology programs at 1 month
Time Frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for all causes combined
between inclusion and 1 month
Percentage effectiveness of pathology programs at 1 month
Time Frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure
between inclusion and 1 month
Percentage effectiveness of pathology programs at 1 month
Time Frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths from all causes combined
between inclusion and 1 month
Percentage effectiveness of pathology programs at 1 month
Time Frame: between inclusion and 1 month
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths due to heart failure
between inclusion and 1 month
Percentage effectiveness of pathology programs at 6 months
Time Frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for all causes combined
between inclusion and 6 months
Percentage effectiveness of pathology programs at 6 months
Time Frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on hospitalizations for heart failure
between inclusion and 6 months
Percentage effectiveness of pathology programs at 6 months
Time Frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths from all causes combined
between inclusion and 6 months
Percentage effectiveness of pathology programs at 6 months
Time Frame: between inclusion and 6 months
Evaluate the effectiveness at 1 month of the PRADO and telemedicine programs, as well as their interaction, on deaths due to heart failure
between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time Frame: between inclusion and 6 months
Average number of consultations per month with the general practitioner
between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time Frame: between inclusion and 6 months
Time between the first consultation with the general practitioner and discharge from hospital
between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time Frame: between inclusion and 6 months
Average number of consultations per month with the cardiologist
between inclusion and 6 months
percentage of effectiveness on the course of care at 6 months
Time Frame: between inclusion and 6 months
Time between the first consultation with the cardiologist and discharge from hospital
between inclusion and 6 months
percentage of days with at least one nursing contact
Time Frame: between inclusion and 6 months
number of days with at least one nursing contact
between inclusion and 6 months
Number of emergency medical contacts
Time Frame: between inclusion and 6 months
are considered as emergency contacts: consultations with emergency increase, or increase for Night, Weekend or Public Holiday; consultations in emergencies; hospitalizations with emergency entry mode
between inclusion and 6 months
percentage of medical appointments made
Time Frame: between inclusion and 6 months
according to the continuity of care index, corresponding to the percentage of appointments made by patients with a doctor
between inclusion and 6 months
Average number of treatment days taken per patient per month
Time Frame: between inclusion and 6 months
For taking sartans treatments
between inclusion and 6 months
Average number of treatment days taken per patient per month
Time Frame: between inclusion and 6 months
For taking beta-blocker treatments
between inclusion and 6 months
Average number of treatment days taken per patient per month
Time Frame: between inclusion and 6 months
Coefficient of variation of the daily dose of loop diuretics, calculated as the average dose between two deliveries
between inclusion and 6 months
percentage of efficiency on the cost of the care pathway at 6 months
Time Frame: between inclusion and 6 months
Cost of care pathways: made up of production costs over 6 months after initial hospitalization, and includes all direct costs, whether medical or non-medical.
between inclusion and 6 months
percentage of physicians offering heart failure programs
Time Frame: between inclusion and 6 months
Beliefs of physicians on the facilitating elements and on the obstacles of these programs
between inclusion and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: François ROUBILLE, PUPH, UH of Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL20_0018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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